Monogram announces availability of HERmark and HER1 and HER3 Total Protein
Assays in Collaborative Biomarker Study
SOUTH SAN FRANCISCO, Calif., June 2 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM) today announced that scientific collaborators have presented additional clinical results on HERmark(TM), the company's novel oncology assay, as a means to measure HER2 total protein and homodimer levels and predict response to Herceptin(R) (trastuzumab) in patients with metastatic breast cancer at the 44th ASCO Annual Meeting taking place in Chicago, Illinois. Monogram also announced the initiation of a Collaborative Biomarker Study involving the company's HERmark Breast Cancer Assay and the HER1 and HER3 Total Protein Assays.
"HERmark is the first diagnostic built upon our VeraTag technology," said Monogram CEO Bill Young. "Today we are announcing two developments that will elevate the profile of HERmark in the oncology community. First, important clinical data presented today demonstrates the superiority of HERmark over FISH testing for HER2. Second, we are initiating a study that will provide an opportunity for participating oncologists to experience first hand the superiority of HERmark in their clinical practices. We look forward to completing our commercial planning and to a future commercial launch of HERmark throughout the U.S."
HERmark Clinical Data
The oral presentation, entitled "Total HER2 and HER2 Homodimer Levels Predict Response to trastuzumab," discussed the findings of a study that investigated the HERmark assay's ability to identify and discriminate among patients with metastatic breast cancer who experienced different degrees of response to trastuzumab. The study was conducted by Allan Lipton, M.D. and colleagues at the Experimental Oncology Research Lab at Penn State/Hershey Medical Center.
"Current testing methods for determination of the likelihood of benefit from Herceptin are not adequate," said Allan Lipton M.D., Professor of Medicine & Oncology at Hershey Medical Center/Penn State University. "The data presented today show that higher HER2 total protein and HER2 homodimer levels, as measured by HERmark, predict which patients have the best chance of responding to Herceptin, even within a population that has already been determined to be FISH+ on central laboratory testing."
The study used Monogram's proprietary HERmark assay to analyze tissue samples from patients with metastatic breast cancer who were treated with Herceptin. Patients had been previously selected for Herceptin therapy by IHC or FISH testing, with most having been selected by IHC performed in a central laboratory. Subsequently, all patient samples were retested using FISH performed at a central laboratory. Using HERmark to measure HER2 total protein and HER2 homodimer levels, the results were compared with the patients' response to treatment with Herceptin.
In Cox multivariate analyses including the variables IHC, FISH, and
HER2 total or HER2 homodimers, the HERmark measurements outperformed both
IHC and FISH, and were identified as independent correlates of both time to
progression (TTP) and overall survival (OS).
-- For TTP: HER2 total protein and HER2 homodimers had hazard ratios of
0.39 (p=0.018) and 0.53 (p=0.092), respectively, while FISH showed
hazard ratios of 1.1 (p=0.8) and 0.92 (p=0.8), respectively.
-- For OS: HER2 total protein and HER2 homodimers had hazard ratios of
0.4 (p=0.058) and 0.35 (p=0.026), respectively, while FISH showed
hazard ratios of 1.4 (p=0.57) and 1.6 (p=0.36), respectively.
Even within the subgroup of patients (74 of 103) that were confirmed
HER2-positive by centrally performed FISH, Monogram's HERmark assay was
shown in multivariate models to be a statistically significant predictor of
time to progression and overall survival following Herceptin treatment.
-- For TTP: HER2 total protein and HER2 homodimers showed hazard ratios
of 0.3 (p=0.002) and 0.53 (p=0.094), respectively.
-- For OS: HER2 total protein and HER2 homodimers showed hazard ratios of
0.25 (p=0.006) and 0.31 (p=0.017), respectively.
Collaborative Biomarker Study
Monogram also announced today that it has initiated a Collaborative Biomarker Study using its VeraTag technology platform. The retrospective study is designed to compare conventional IHC and FISH methods of HER2 testing with the quantitative measurements of HER2 total protein and HER2 homodimers provided by Monogram's HERmark Breast Cancer Assay. Additionally, the study aims to describe the expression/co-expression profiles identified by Monogram's HER1 and HER3 Total Protein Assays along with HER2 total protein and homodimer levels identified by HERmark to facilitate analyses of how such measurements may correlate with certain laboratory and clinical parameters, including disease progression.
Initially, the study will be conducted as a pilot program in up to fifteen sites. Breast cancer patients will already have been selected for treatment with conventional HER2 tests and outcomes will subsequently be compared to both the conventional and VeraTag measurements.
"HERmark represents a major step forward in the assessment of HER2 expression and has the potential to facilitate significantly more accurate selection of therapies for breast cancer patients," said Young. "We expect that this Collaborative Biomarker Study will add to the body of data describing HER2 total protein and HER2 homodimer expression and their relationship to clinical outcomes. Assessing the quantitative levels of expression and co-expression of HER1 and HER3 proteins in conjunction with HER2 measurements by HERmark will substantially increase our knowledge of how the expression of these HER-family proteins are represented in breast cancer."
HERmark is a proprietary diagnostic that accurately quantifies HER2 total protein expression and HER2 homodimerization in patients with breast cancer. Preliminary data from three cohorts of Herceptin-treated patients with metastatic breast cancer who were identified as "HER2 positive" by conventional assays suggest that HERmark can identify patients who are likely to respond to Herceptin with greater precision than currently available tests, permitting stratification of patients according to their degree of clinical benefit from the drug. Additional studies of HERmark for breast cancer in both the metastatic and adjuvant settings are in progress.
VeraTag is a proximity-based assay technology platform that accurately quantifies proteins and functional protein complexes. This platform provides a researcher or clinician a more thorough understanding of protein-protein interactions or signaling pathway activity allowing for disease characterization at the molecular level. Assays based on the VeraTag technology platform are designed to run on standard formalin-fixed paraffin embedded (FFPE) patient samples.
Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company's technology is also being used by numerous biopharmaceutical companies to develop new and improved anti-viral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at http://www.monogrambio.com.
Forward Looking Statements
Certain statements in this press release are forward-looking. These forward-looking statements include the ability of VeraTag technology and the HERmark assay to predict response to Herceptin or to significantly improve the information available to physicians, results of studies intended to demonstrate clinical utility of HERmark and the potential commercialization of the HERmark assay or other assays based on the VeraTag technology platform. These forward-looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to: risks and uncertainties relating to the performance of our products, including HERmark; the growth in revenues; the risk that our VeraTag assays, including HERmark may not predict response to Herceptin or other therapeutic agents; the risk that we may not be able to obtain additional cohorts of patient samples for additional VeraTag studies, our ability to successfully conduct clinical studies, including the Collaborative Biomarker Study, and the results obtained from those studies; whether larger confirmatory clinical studies will confirm the results of initial studies; our ability to establish reliable, high-volume operations at commercially reasonable costs; actual market acceptance of our products for patient use and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; whether payers will authorize reimbursement for our products and services and the amount of such reimbursement that may be allowed; whether the FDA or any other agency will decide to further regulate our products or services; whether the draft guidance on Multivariate Index Assays issued by FDA will be subsequently determined to apply to our current or planned products; whether we will encounter problems or delays in automating our processes; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; restrictions on the conduct of our business imposed by the Pfizer, Merrill Lynch and other debt agreements; the impact of additional dilution if our convertible debt is converted to equity; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.
VeraTag and HERmark are trademarks of Monogram Biosciences, Inc.
Herceptin is a registered trademark of Genentech, Inc.
contacts: Alfred G. Merriweather Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: 650 624-4576 Tel: 415 677-2700
|SOURCE Monogram Biosciences, Inc.|
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